Archive
Medicine
FDA has been cultivating partners in the drug industry, too. Their new goal is to "make safe and
effective drugs available" to Americans, whether from the most conventional processes or from the newest
biotechnology. FDA will never compromise on safety, but that is not stopping them from cutting out
bureaucracy. Scios, Inc., a northern California pharmaceutical manufacturer, recently wrote the agency
thanking it for its new approach, in which inspectors work with companies to identify and correct problems,
rather than just issue reports of deviations.(5) Citing a recent visit to its facility by an FDA inspector, a company vice president remarked on the frustrating history of industry relations with the agency, noting that, "... since the late 1980s, relations between FDA and its regulated industries have been on a steady and disheartening decline." However, the new approach taken by the FDA inspection team was a refreshing change: "Our goal is to get safe and effective therapies on the market as soon as possible; you've contributed to this effort," the executive states in commenting on the new and welcome change in the FDA.
FDA has been working in partnership with industry researchers to create safe, effective new drugs
against cancer and other killers, and to market them fast. For example, they worked with Merck & Co., Inc.,
to make an important new tool in the fight against HIV/AIDS available faster. Knowing that scientists at
Merck were nearing a breakthrough on a new drug to treat HIV/AIDS, the FDA set up advance teams for
regulatory review and manufacturing inspection to reduce delays in the approval process. In particular,
the Baltimore district office of FDA worked with Merck's Elkton, Virginia, facility to integrate the
review process with the construction of the new manufacturing plant and validation of the manufacturing
process. As a result, Crixivan, one of a new class of protease inhibitors offering significant new
treatment in the fight against HIV/AIDS, was cleared for the market in 42 days, the fastest ever approval
of a new drug by the FDA.
